Viz RV/LV
Viz. ai, inc.
Product Details
Model Identifier
Manufacturer
Viz. ai, inc.
Product
Viz RV/LV
Version
Unknown
Date Cleared
08/29/2022
FDA Submission No.
Category
MIMPS
Model Characteristics
Inclusion Criteria
Non-gated, CT Pulmonary Angiography (CTPA)
Exclusion Criteria
Unknown
Instructions for Use
Not available
Indications for Use
Indication of Use
The Viz RV/LV Software device is designed to measure the maximal diameters of the right and left ventricles of the heart from a volumetric CTPA acquisition and report the ratio of those measurements. Viz RV/LV analyzes cases using an artificial intelligence algorithm to identify the location and measurements of the ventricles. The Viz RV/LV software provides the user with annotated images showing ventricular measurements. Its results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of CTPA cases.
Intended User
Radiologist
Age
Unknown
Anatomy
Chest
Modality
CT
Output
The RV/LV Summary Report summarizes the results of the ventricle analysis and shows the slices with the maximum right and left ventricular diameters. The lines measuring the maximum RV and LV diameters are displayed over the original CTPA slice image, along with the lengths of the largest RV and LV diameters, and the RV/LV ratio.
Details on Training Data Sets
Details on Training Data Sets
No. of Cases
Unknown
Age Range (Years)
Unknown
Sex (%)
- Female: Unknown
- Male: Unknown
- Unknown: Unknown
Output
Unknown
Race (%)
- White: Unknown
- Black or African American: Unknown
- American Indian or Alaska Native: Unknown
- Asian: Unknown
- Native Hawaiian or Other Pacific Islander: Unknown
- Unknown: Unknown
Ethnicity (%)
- Hispanic or Latino: Unknown
- Not Hispanic or Latino: Unknown
- Unknown: Unknown
Geographic Region (%)
- USA: Unknown
- International: Unknown
- Unknown: Unknown
Scanner Manufacturer(s)
Unknown
Scanner Model(s)
Unknown
Model Performance
Study Type
Performance Testing Type
Stand-Alone Performance
Standalone Model Performance
Reference Standard (Ground Truth)
Interpretation by Reviewing Clinician
No. of Cases
Unknown
Age Range (Years)
Unknown
Sex (%)
- Female: Unknown
- Male: Unknown
- Unknown: Unknown
Race (%)
- White: Unknown
- Black or African American: Unknown
- American Indian or Alaska Native: Unknown
- Asian: Unknown
- Native Hawaiian or Other Pacific Islander: Unknown
- Unknown: Unknown
Ethnicity (%)
- Hispanic or Latino: Unknown
- Not Hispanic or Latino: Unknown
- Unknown: Unknown
Geographic Region (%)
- USA: Unknown
- International: Unknown
- Unknown: Unknown
Output
Unknown
Scanner Manufacturer(s)
Unknown
Scanner Model(s)
Unknown
No. of Sites
4
Model Accuracy
Unknown
Model Sensitivity
Not provided
Model Specificity
Not provided
Reader Study Performance
No. of Readers
N/A
No. of Cases
N/A
No. of Sites
N/A
Output
N/A
Age Range (Years)
N/A
Sex (%)
- Female: N/A
- Male: N/A
- Unknown: N/A
Race (%)
- White: N/A
- Black or African American: N/A
- American Indian or Alaska Native: N/A
- Asian: N/A
- Native Hawaiian or Other Pacific Islander: N/A
- Unknown: N/A
Ethnicity (%)
- Hispanic or Latino: N/A
- Not Hispanic or Latino: N/A
- Unknown: N/A
Geographic Region (%)
- USA: N/A
- International: N/A
- Unknown: N/A
Scanner Manufacturer(s)
N/A
Scanner Model(s)
N/A
Model Accuracy
N/A
Model Sensitivity
N/A
Model Specificity
N/A
Model Limitations, Warnings, & Precautions
Model Limitations, Warnings, & Precautions
Supported Scanner Manufacturer(s)
All
Slice Thickness
Unknown
Contrast Use
Unknown
MRI Field Strength
Unknown
Reconstruction Kernel Used
Unknown
Alternative Choices
Alternative Choices
Previous Version(s)
Unknown
Predicate Device(s)
Contact Information
Contact Information
Point of Contact Name
Unknown
Email
Unknown
Additional Details
Related Use Cases
Unknown